Thermo Fisher Scientific · 20 hours ago
Data Integrity Manager
Greenville, North Carolina, USA
Full-time
Onsite
Senior Level
6+ years expThermo Fisher Scientific is a global leader in providing innovative solutions for scientific challenges. As a Data Integrity Manager, you will ensure product quality and regulatory compliance within GMP manufacturing environments while leading data integrity initiatives and collaborating cross-functionally to drive quality excellence.
Research
Responsibilities
Assist in preparation of the Data Integrity (DI) Site Governance Team meetings
Assist with providing metrics to the Director of the Global Data Integrity network to include pulling data from TrackWise, Audits, Power BI, and other site systems
Monitor equipment and instrumentation as indicated in the site data integrity remediation plan and ensure it complies with 21CFR Part 11, Annex 11, and Data Integrity regulations
Support and lead Data Integrity initiatives across the site to maintain and proactively improve the data integrity culture
Coordinate and track the Data Integrity Remediation Plan to ensure deliverables are on target and executed as committed within the site
Provide support on the development of Data Integrity awareness training and compliance with data integrity regulations
Create/update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations
Coordinate the DI Surveillance program to audit GMP areas within the site for compliance to establish documentation and data integrity standards, practices, and procedures
Collaborate on projects to meet customer, business, and regulatory requirements
Present DI Metrics to Site leadership monthly. Provide approvals for DI related deviations, CAPA, and change controls. Assist in data integrity risk assessments
Qualification
Required
Bachelor's Degree in Chemistry, Biology, Microbiology, Engineering, or similar scientific, engineering or related technical field; Advanced degree preferred
At least 6 - 8 years of experience in quality assurance in a GMP-regulated pharmaceutical/biotech environment
Proven expertise in quality systems including investigations, CAPAs, change control, document control, training
Experience with risk assessment methodologies and root cause analysis
Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211, ICH guidelines
Proficiency with quality management systems and standard office software
Strong technical writing and documentation skills
Excellent verbal/written communication and interpersonal abilities
Demonstrated project management and organizational capabilities
Strong analytical and problem-solving skills
Ability to work independently and collaborate effectively in cross-functional teams
Ability to work effectively with diverse teams
Customer-focused mindset with strong attention to detail
Fluency in English required; additional languages valued
Preferred
Advanced degree preferred
Experience hosting regulatory inspections and customer audits preferred
Data integrity and computer system validation experience preferred
Professional certifications valued (e.g. ASQ CQE, CQA)
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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